Sr. Manager, Regulatory Affairs

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow uson LinkedInand Instagram.

JOB SUMMARY:

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Manage and support the preparation of US regulatory submissions including INDs and NDA/BLAs as well as regulatory submissions outside the US on assigned projects.
• Support regulatory strategies for assigned projects via researching regulations and guidelines ensuring alignment with regional requirements that will result in the on-time submission and approval of new products.
• Working with Regulatory Operations, compile, prepare and submit IND, BLA/NDA and additional US regulatory filings as necessary to implement the agreed upon strategy.
• Provide support to Global Regulatory Lead (GRL) for defined deliverables that may include, and not limited to, leading identified workstreams; attend clinical study team meetings; track and keep GRL and reg subteams current with status of regulatory submissions and any changes in strategies.
• Support GRL in the coordination and preparation of Health Authority meetings.
• Review/revise/draft Standard Operational Procedures as required to assure compliance with Global Regulations and Guidance Documents.
• Manage regulatory timelines and manage/communicate timeline and/or content risks to GRL ensuring that regulatory strategies are executed within those approved timelines.
• Maintains current with FDA regulations and guidance regarding INDs, BLAs/NDAs, while developing familiarity with global regulations.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree required with advanced degree (MS; PhD, PharmD) a plus
• Five (5) to eight years regulatory strategy experience in the biotech/pharmaceutical industry.
• Ability to maintain high ethical standards.
• Excellent organizational skills, attention to details, and communication skills.
• Ability to work as part of a team, both in a leadership on assigned duties and as a contributing member of the company.
• Ability to develop and maintain positive working relationships across cross-functional teams.
• Strong interpersonal skills and effective written and verbal communication and presentation skills.
• Thorough knowledge of US FDA regulations regarding product development (IND), BLA/NDA with a sense of curiosity driving continuous learning and program success.
• Computer literate (e.g., MS Word, MS PowerPoint, MS Excel).

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.